A Cluster Randomised Controlled Trial on the Effects of Long-term Home-based Exercise for Patients With Chronic Obstructive Pulmonary Disease With Recent Exacerbation: the COPDtoParis Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Five-repetition sit-to-stand test
研究概览
简要总结
This randomised controlled trial (RCT) aims to investigate the effect of long-term, interactive home-based cycle-exercise on patients with Chronic Obstructive Pulmonary Disease (COPD) after a COPD exacerbation requiring hospitalisation. The investigators aim to investigate if patients can maintain or improve the effects of pulmonary rehabilitation in terms of walking distance, intensity of COPD symptoms, health related quality of life and Quality Adjusted Life-Years.
Participants will cycle on a pedal-exerciser in the comfort of staying in the participants' own home, whilst getting visual feedback from the 4Mvideo app. The 4Mvideo technology is a Danish designed software system, where users can cycle forward a recording of a cyclist by treading on a pedal-exerciser, thereby getting some of the experience of a real-life cycling trip at home.
The investigators will compare the clinical outcomes and daily activity levels with that of a control group consisting of COPD patients.
详细描述
Patients with chronic obstructive pulmonary disease (COPD) have a higher risk of experiencing disability, and even though participating in pulmonary rehabilitation (PR) are efficient for regaining strength, function and relieving symptoms, effects prove difficult to maintain. Furthermore, physical attendance to outpatient PR is challenging for COPD patients, many of whom are bound to their home, due to said disability and symptoms. Even in patients who follow through with the PR programme, adherence to exercise after is a major challenge.
The investigators hypothesise that an intervention group of COPD-patients, who will receive home-based cycle exercise will maintain or even improve effects on physical fitness from PR, in terms of walking distance, daily activity levels (DAL), exercise tolerance, disease prevention and health related quality of life (HRQoL).
Furthermore, the investigators hypothesise that the participants express improved motivation in terms of adhering to exercise, when participating in home-based, interactive group cycle exercise.
It is expected to measure changes in DAL, lung function, levels of dyspnoea, exercise tolerance, walking distance, mobility, COPD symptoms, activity of daily living (ADL) related performance and HRQoL of the participants, along with assessing disease prevention. Data is compared intrapersonal and in-between groups to identify differences in outcomes at an individual level, and between intervention- and control group. Furthermore, the investigators expect to uncover identifiable in-depth insights into the values and beliefs towards exercising amongst participants.
40 participants are recruited amongst COPD patients that live in Aalborg Municipality and are admitted at Aalborg University Hospital, hospitalised due to acute exacerbation of COPD. After being discharged participants are referred to rehabilitation, for most in their own home. After rehabilitation participants are randomized into either intervention group who will exercise on exercise bikes connected with tablets in their own home. The control group will receive usual care, which consists of offers of exercising in their own home according to a programme or participating in exercise at a facility center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants are anonymised with a participant identification
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults at age > 18 years old
- •Hospital admission with COPD exacerbation with pre-existing COPD diagnosis
- •Citizens of Aalborg Municipality
- •Able to provide informed consent
- •Accepting of referral to rehabilitation
排除标准
- •Terminal illness
- •Unstable heart disease, i.e., ischemic heart disease, cardiac rhythm disorders
- •Other conditions preventing participating in cycle exercise, e.g., amputation, regimens or earlier or upcoming surgeries preventing seated position, blindness
- •Inability to understand basic Danish oral and written information or giving informed consent.
结局指标
主要结局
Five-repetition sit-to-stand test
时间窗: Changes from baseline lower limb function at follow-up are assessed at 12 months
The five-repetition sit-to-stand test is a test of lower limb function that measures the fastest time taken to stand five times from a chair with arms folded
次要结局
- Daily Activity Levels(Changes from baseline activity during rehabilitation at follow-up are assessed 12 months)
- Lung function Test (FEV1)(Changes from baseline lung function at follow-up are assessed at 12 months)
- Level of Dyspnea with the Modified Medical Research Council Dyspnoea Scale (mMRC)(Changes from baseline and at follow-up are assessed at 12 months)
- Health Related Quality of Life with St. George's Respiratory Questionnaire (SGRQ)(Changes from baseline health related quality of life at follow-up are assessed at 12 months)
- Life-Space Assessment (LSA)(Changes from baseline mobility at follow-up are assessed at 12 months)
- COPD Assessment Test (CAT)(Changes from baseline COPD impact at follow-up are assessed at 12 months)
- Tilburg Frailty Indicator (TFI)(Changes from baseline frailty at follow-up are assessed at 12 months)
- Clinical Frailty Scale (CFS)(Changes from baseline frailty at follow-up are assessed at 12 months)
- Canadian Occupational Performance Measure (COPM)(Changes from baseline performance at follow-up are assessed at 12 months)
- Six Minutes Walk Test (6MWT)(Changes from baseline and at follow-up are assessed at 12 months)
- Short Physical Performance Battery (SPPB)(Changes from baseline mobility at follow-up are assessed at 12 months)
- Readmissions(Readmissions are assessed at 12 months)
- Survival rates(Mortality is assessed at 12 months)
- EuroQol 5-Dimensions 5-Level (EQ-5D-5L)(Changes from baseline mobility at follow-up are assessed at 12 months)
- 30 Seconds Sit To Stand Test(Changes from baseline mobility at follow-ups are assessed at 12 months)
研究者
Anna Lei Stoustrup
PhD Fellow
Aalborg University Hospital